[No public or meaningful name is available]

Endpoint summary

Description of key information

Acid Red 195 is to be considered as a non-irritant to the skin and eye of rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

None

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Guidelines followed

GLP compliance:

yes

Specific details on test material used for the study:

- Test article: FAT 20042/D
- Additional specification: Neolan Rosa BE ZP feucht
- Batch No.: 276
- Purity/Contents: ca. 50 %
- Physical properties: solid; black-red humid lumps
- Storage conditions: room temperature
- Validity: October, 1998
- Safety precautions: gloves and face masks
- Test material received: November 19, 1993

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Weight at study initiation: 2380 t o 2650 g
- Housing: Housed individually in metal cages
- Diet: rat food (Nafag, No. 814, Gossau) ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

other: A control gauze patch was applied to the contralateral flank of the animals, which were exposed to the test substance on right flanks.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 h

Observation period:

1, 24, 48, and 72 hours

Number of animals:

Three female rabbits

Details on study design:

TEST SITE
An area of at least 36 cm² was shaved on both flanks of the animals. A gauze patch bearing 0.5 g of the test article was applied to the right flank of each animal. The skin area exposed directly to the test article was approx. 6 cm². A control gauze patch was applied to the contralateral flank. Before application both patches were moistened with distilled water.
The patches were loosely covered with an aluminum foil and held in place for 4 hours by an adhesive tape. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No reactions were observed.

Other effects:

None

None

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 20042/D can be classified as non-irritant in albino rabbits

Executive summary:

An in vivo study was conducted to evaluate the skin irritation potential of the test substance in rabbits according to OECD Guideline No. 404. An area of at least 36 cm² was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (approx. 12-16 cm²) bearing 0.5 g of the test article was applied to the right flank of each animal. The patches were loosely covered with an aluminum foil (approx. 36 cm²) and held in place for 4 hours by an adhesive tape. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system. Because no reactions were observed at 24 hours to 72 hours after removing the bandages, the test was ended after the 72 hours evaluation. Hence,FAT 20042/D can be classified as non-irritant in albino rabbits.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

None

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Guidelines followed

GLP compliance:

yes

Specific details on test material used for the study:

- Test article: FAT 20042/D
- Additional specification: Neolan Rosa BE ZP feucht
- Batch No.: 276
- Purity/Contents: ca. 50 %
- Physical properties: solid; black-red humid lumps
- Storage conditions: room temperature
- Validity: October, 1998
- Safety precautions: gloves and face masks
- Test material received: November 19, 1993

Species:

rabbit

Strain:

other: Chbb:NZW

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GMBH,Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Weight at study initiation: 2030 to 2610 g.
- Housing: Housed individually in metal cages
- Diet: Nafag, No. 814, Gossau, Switzerland, ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20±3 °C
- Humidity: 30-70 %
- Photoperiod: 12 hours light cycle day

IN-LIFE DATES: From: To: January 11, 1994 to February 15, 1994

Vehicle:

not specified

Controls:

other: untreated right eye

Amount / concentration applied:

- Amount(s) applied: 100 mg

Duration of treatment / exposure:

Unwashed eye: unspecified (not rinsed after single instillation)

Observation period (in vivo):

The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of FAT 20042/D

Duration of post- treatment incubation (in vitro):

None

Number of animals or in vitro replicates:

Three animals (one males and two females)

Details on study design:

PROCEDURE:
The test article was applied with a spatula. 100 mg of FAT 20042/D was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test article. The right eye remained untreated and served as a control. The animals were checked dailyfor systemic symptoms and mortality (only findings reported).

The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of FAT 20042/D according to the OECD scoring system. In order to determine the reversibility of the eye reactions additional evaluations of the ocular reactions were needed in this study. A slit-lamp was used to facilitate the evaluation. The irritant/corrosive potency of FAT 20042/D was classified according to Council Directive 67/548/EEC, adapted to technical progress by Commission Directive 93/21/EEC.

Irritation parameter:

conjunctivae score

Basis:

animal: 824

Remarks:

mean score

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 d

Irritation parameter:

cornea opacity score

Basis:

animal: 824

Remarks:

mean score

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

iris score

Basis:

animal: 824

Remarks:

mean score

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible within: 24 h

Irritation parameter:

chemosis score

Basis:

animal: 824

Remarks:

mean score

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Irritation parameter:

conjunctivae score

Basis:

animal: 086

Remarks:

mean score

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 7 d

Irritation parameter:

cornea opacity score

Basis:

animal: 086

Remarks:

mean score

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal: 086

Remarks:

mean score

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible within: 24 h

Irritation parameter:

chemosis score

Basis:

animal: 086

Remarks:

mean score

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Irritation parameter:

conjunctivae score

Basis:

animal: 025

Remarks:

mean score

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 d

Irritation parameter:

cornea opacity score

Basis:

animal: 025

Remarks:

mean score

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal: 025

Remarks:

mean score

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible within: 24 h

Irritation parameter:

chemosis score

Basis:

animal: 025

Remarks:

mean score

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Irritant / corrosive response data:

The mean values of the readings 24 to 72 hours after instillation are below the threshold of significance, and 0 for the conjunctivae.

Other effects:

None

None

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 20042/D is classified as non-irritant to the eyes of rabbit.

Executive summary:

Acute eye irritation/corrosion study in albino rabbits was performed to determine the irritant or corrosive potency of FAT 20042/D in the albino rabbit eye and the associated mucous membranes. This test was based on OECD Guideline 405. 100 mg of FAT 20042/D was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test article. Because reactions were observed till 72 hours after instillation of the test article, the observation period was extended to 7 days to determine the reversibility of the eye reactions. The mean values of the readings at 24, 48 and 72 hours after instillation were below the threshold of significance. Also changes observed were fully reversible within 7 days. Therefore, as per the Regulation (EC) No. 1272/2008, FAT 20042/D is not an eye irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin:

Acid Red 195 was investigated in in vivo studies for the potential to cause skin irritation.

The key study (1993) was conducted according to OECD Guideline No. 404 using rabbits. An area of at least 36 cm² was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (approx. 12-16 cm²) bearing 0.5 g of the test article was applied to the right flank of each animal. The patches were loosely covered with an aluminum foil (approx. 36 cm²) and held in place for 4 hours by an adhesive tape. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system. Because no reactions were observed at 24 hours to 72 hours after removing the bandages, the test was ended after the 72 hours evaluation. Hence, FAT 20042/D can be classified as non-irritant in albino rabbits.

An in vivo study (1979) was conducted to evaluate the skin irritation potential of the test substance in rabbits according to the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). The test substance was applied under two patches (each on an intact and an abraded site) on the backs of six animals (3/sex). Each test site received 0.5 g of substance on a 2.5 cm² gauze pad for 24 h under occlusive conditions. No erythema or odema was seen in all animals involving both intact and abraded sites 24 as well as 72 h after application of the test substance. Under the study conditions, the test substance was considered to be non-irritating to skin.

In another supporting study (1974), skin irritation potential of the test substance was evaluated according to the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). The test substance was applied under two patches (each on an intact and an abraded site) on the backs of six rabbits (3/sex). Each test site received 0.5 g of substance on a 2.5 cm²gauze pad for 24 and 72 h under occlusive conditions. Test sites were assessed for erythema and oedema at 24 and 72 h after patch removal. No erythema and odema was seen with both intact and abraded sites in all animals 24 and 72 h after application of the test substance. Under the study conditions, the test substance was considered to be non-irritating to skin.

The available studies indicate that Acid Red 195 did not lead to skin irritation on intact as well as abraded skin.

Eye:

Acid Red 195 was investigated in in vivo studies for the potential to cause eye irritation.

The key study was based on OECD Guideline 405. 100 mg of FAT 20042/D was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test article. Because reactions were observed till 72 hours after instillation of the test article, the observation period was extended to 7 days to determine the reversibility of the eye reactions. The mean values of the readings at 24, 48 and 72 hours after instillation were below the threshold of significance. Also changes observed were fully reversible within 7 days. Therefore, as per the Regulation (EC) No. 1272/2008, FAT 20042/D is not an eye irritant.

In a supporting study (1979) conducted according to guideline proposed in "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO), FAT 20042/B in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the rabbits. The irritation score was found to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae. Therefore, it was concluded that, FAT 20042/B did not lead to irritation when applied to the rabbit eye mucosa.

In another supporting study (1974) again conucted according to guideline proposed in "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO), amounts of 0.1 g of FAT 20042/A were introduced into the conjunctival sac of the left eye of rabbits with a spatula. The irritation index was found to be 0 for the cornea, 0 for the iris and 2.4 for the conjunctivae. Therefore, the test substance did induce minimal irritation in eyes as seen with the scores for conjunctiva, when eyes were not rinsed. However the scores fail to fulfil the criteria for classification as specified by the Regulation (EC) No. 1272/2008, hence FAT 20042/A is not considered to be an eye irritant.

Based on the above discussion, Acid Red 195 can be considered as not irritating to the eyes.

Justification for classification or non-classification

Based on the above stated assessment, Acid Red 195 is to be considered as a non-irritant to the skin and eye of rabbits, hence no classification is warranted according to CLP [Regulation (EC) No 1272/2008].